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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 023 05 18 000
Date submitted: 5/7/2018
Manufacturer:Siemens Healthcare Diagnostics
Device Type:Dimension clinical chemistry system and Dimension Vista System, Alkaline Phosphatase Calibrator (ALPI CAL)
Description:IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Alkaline Phosphatase
Medical Device Identifier:1) Dimension ALPI CAL:
- Catalog Number: DC150
- Siemens Material Number : 10714028
- Lot Number: 7FD041, 7GD016, 7HD041, 7JD080, 7KD059, 7KD079

2) Dimension Vista ALPI CAL:
- Catalog Number: KC331
- Siemens Material Number : 10714029
- Lot Number: 7GD017, 7KD040
Reason of Field Safety Corrective Action:Siemens Healthcare Diagnostics has received customer complaints regarding Alkaline Phosphatase (ALPI) calibrator vials containing particulate matter.
Remedy Action:•Continue to use Dimension and Dimension Vista ALPI calibrator lots listed above.
•If your laboratory chooses not to use the product, complete and return the Product Replacement Form for your laboratory’s no-charge replacement needs.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:A0780F5E7C201
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics.pdf